FDA Adverse Event Injury Summary report: N

BEBIRD W3 EAR CLEANING OTOSCOPE SYSTEM

MDR report key: 19239164 · Received May 2, 2024

Report

Report Number
MW5154498
Event Type
Injury
Date Received
May 2, 2024
Date of Event
April 26, 2024
Report Date
April 27, 2024
Manufacturer
BEBIRD / HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD
Product Code
ERA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I PURCHASED BEBIRD W3 EAR CLEANING OTOSCOPE SYSTEM FROM WALMART (B)(6), ON FRIDAY, APRIL 26. I BELIEVED I WAS HAVING WAX BUILD UP IN MY EAR AND I WENT TO WALMART TO LOOK AT THE EAR CARE AISLE. I NOTICED THIS PRODUCT WHICH ALLOWS THE USER TO SEE IN THE EAR CANAL. I PURCHASED THE ITEM AND BROUGHT IT HOME FOR USE. THE PRODUCT SHOULD BE RECALLED. THE END PIECE SEPARATED FROM THE MAIN DEVICE AND WAS DISLODGED IN MY EAR. VERY SCARY AND HARMFUL. FORTUNATELY I HAVE LIMITED MEDICAL EXPERIENCE AND I WAS ABLE TO USE A SURGICAL TOOL TO REMOVE THE END PIECE FROM MY EAR CANAL. 99% OF U.S. CONSUMERS ARE NOT GOING TO HAVE THE SKILL TO REMOVE THE END PIECE FROM THEIR OWN EAR. THIS IS GOING TO REQUIRE AN ER VISIT. THE END PIECE IN THE EAR WAS PAINFUL AND COULD HAVE HARMED MY BODY. THE PRODUCT SHOULD BE RECALLED IMMEDIATELY DUE TO DEFECTIVE DESIGN. THERE ARE ONLY A FEW THREADS ON THE END PIECE WHICH CAUSED SEPARATION. BEBIRD EVEN WARNS THE CUSTOMER IT MAY BECOME SEPARATED. THIS IS COMPLETELY UNACCEPTABLE AND DANGEROUS. I AM GRATEFUL I WAS ABLE TO HELP MYSELF, HOWEVER THIS PRODUCT SHOULD BE PULLED OFF SHELVES IMMEDIATELY. I COULD SEE A POTENTIAL USE CASE FOR THIS PRODUCT IF PROPERLY DESIGNED, BUT THE CURRENT DESIGN IS DOWNRIGHT SCARY AND DANGEROUS. FDA LISTING NUMBER (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
591662 BEBIRD W3 EAR CLEANING OTOSCOPE SYSTEM OTOSCOPE ERA BEBIRD / HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD W3-WM-BK

Patients

Seq Age Sex Outcome Treatment
1 35 YR Male Other| R